PMA P210022S002
- Device
- Alinity m CMV
- Applicant
- Abbott Molecular, Inc.
- PMA number
- P210022
- Supplement
- S002
- Product code
- PAB
- Decision date
- 2022-11-28
- Generic name
- Cytomegalovirus (cmv) dna quantitative assay
- Approval order statement
- Implement a large-scale manufacturing process for the Alinity m CMV AMP Tray 1.
Current openFDA PMA Record#
- Device
- Alinity m CMV
- Applicant
- Abbott Molecular, Inc.
- PMA number
- P210022
- Supplement
- S002
- Product code
- PAB
- Generic name
- Cytomegalovirus (cmv) dna quantitative assay
- Decision date
- 2022-11-28
- Decision code
- OK30
- Date received
- 2022-11-03
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Implement a large-scale manufacturing process for the Alinity m CMV AMP Tray 1.